Insight Instruments Recalls Cornea Coat Hydroxypropylmethylcellulose Syringes
Insight Instruments is recalling Cornea Coat syringes because they were marketed without an approved NDA or ANDA.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Insight Instruments, Inc. is recalling Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringes. The recall involves 316,464 kits distributed nationwide and in Puerto Rico.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The affected product numbers are 60010, 40201, 40202, 40203, 40204, 40205, and 40206.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance. The recalling firm is Insight Instruments, Inc., located in Stuart, Florida.
The recalled product
- Product
- Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
- Manufacturer
- Insight Instruments, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 316,464
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Product Number (s): 60010
- 40201
- 40202
- 40203
- 40204
- 40205
- 40206.
Distribution
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